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TruSignal SpO2 Disposable Sensor, Pediatric/Infant, 0.3M
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref TS-AP-xx
Identity
- Trade Name
- TruSignal SpO2 FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- TruSignal SpO2 Disposable Sensor, Pediatric/Infant, 0.3M EUDAMEDTRUSIGNAL SPO2 TS-AP FDA UDI
- Model / Reference
- TS-AP-xx EUDAMEDTS-AP FDA UDI
- Description
- TRUSIGNAL SPO2 TS-AP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682103220 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682103220 EUDAMED
- FDA Product Code
- DPZ FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES EUDAMED
- GMDN Term
- Pulse oximeter probe, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2710 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: General-purpose multi-parameter bedside monitor
TruSignal SpO2 Disposable Sensor, Pediatric/Infant, 0.3M by GE Healthcare Finland Oy — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840682103220 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (2)
- EUDAMED 11c28341-ae3c-40f3-ae80-99b538e219c8 61 fields · synced Jun 19, 2026
- FDA UDI e6df9f7c-cc06-498a-84e7-46441076c12b 36 fields · synced May 30, 2026